The DIS600i has 6 stirred test vessels to measure the dissolution rate of tablets, capsules or patches. The rate at which the tablet or capsule dissolves is critical to its therapeutic efficiency and can be correlated to the bioavailability of the drug.
The DIS600i provides an uncluttered design with two rows of 3 vessels, which are heated in a water bath by an independent heater/circulator. The interchangeable USP-compliant paddles and baskets allow the analyst to change the method in a few seconds without any further height adjustment.
DIS600i Dissolution Tester
The DIS600i has a user friendly operating procedure that is much easier to use than other systems overladen with complex and unnecessary software functionality. It also has automatic tablet dropping features to drop tablets simultaneously into the vessels at the start of the test. The analyst can choose to use this automatic function to drop the tablets simultaneously or to manually introduce them sequentially.
The DIS600i can be configured according to USP:
- Apparatus 1 (basket)
- Apparatus 2 (paddle)
- Apparatus 5 (paddle over disc)
- Apparatus 6 (rotating cylinder)
A high precision “Audit-Proof” version - DIS 6000 EMC - is also available with tolerances that are significantly better than FDA’s mechanical qualification requirements by a factor of 2. The DIS 6000 EMC applies the latest state of the art technologies to provide a whole new level of variation control and tolerances.
The DIS 6000 EMC and their associated parts are designed and manufactured differently from standard dissolution testers to ensure that the variations in dimensions and tolerances to wobble, vibration, verticality, vessel centering, height and rotation speed is reduced by more than half.
DIS 6000 ECM
The dissolution community has long recognized that one of the major contributors to result variability is due to vessel dimensions and irregularities. Usually, dissolution vessels are individually made by manual glass blowing technique from extruded glass tubing. The DIS 6000 EMC dissolution vessels are manufactured by a more sophisticated technique that guarantees the inside diameter tolerance and blemish-free spherical radius to be only 10% of the typical tolerances.
The introduction of extended or delayed release drugs resulted in dissolution tests that could potentially run for over 12 hours, 24 hours or even longer. These demands coupled with the rise of multi-point testing for in-vivo/in-vitro correlation led to the use of automated dissolution systems to increase efficiency and reproducibility.
‘Online’ or automated dissolution testing is essentially a continuous flow technique whereby the media from each vessel is circulated continuously through a series of flow cells in a suitable UV/Vis spectrophotometer, which will acquire the spectra of the dissolved sample. This is the more popular approach for automated dissolution testing.
However, for instances whereby a UV/Vis spectrophotometer is not suitable – such as drugs without chromophores, a HPLC system can be used instead. The HPLC system will offer better sensitivity than a UV/Vis spectrophotometer for analyzing sustained release drugs and low dosage formulations. As the HPLC detector will only accept one sample at a time, the samples are usually deposited in a sealed vial on an autosampler.
Online Dissolution Testing
The advantages of online dissolution testing are:
- Eliminate potential errors from manual sampling and off-line analysis
- Increased precision and accuracy
- Higher throughput
- Lower consumable costs
- Saves time / Less labour intensive